Schizophrenia Clinical Trial
Official title:
Assessing the Effect of Compensatory Cognitive Intervention for Functional Capacity, Cognitive Functions and Severity of Symptoms Among People With Severe Mental Illness
The aim of this study is to assess the efficacy of a short term compensatory cognitive group intervention - the Compensatory Cognitive Training (CCT) among people with severe mental illnesses, receiving ambulatory treatment
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - basic knowledge in Hebrew - diagnosed according to the ICD -10 with severe mental illness: schizophrenia, bipolar disease, schizoaffective disorder or major depression - Patients are treated with neuroleptic medication for at least four weeks. Exclusion Criteria: - acquired neurological disorders including dementia and brain injury. - Developmental neurological disorders including developmental intellectual disability and autistic spectrum disorders. - Regular Electro convulsive therapy treatment with frequency of twice a month or more. - People to whom a guardian has been appointed - Current addiction |
Country | Name | City | State |
---|---|---|---|
Israel | Shalvata mental health center | Hod HaSharon |
Lead Sponsor | Collaborator |
---|---|
Shalvata Mental Health Center | Tel Aviv University |
Israel,
Twamley EW, Burton CZ, Vella L. Compensatory cognitive training for psychosis: who benefits? Who stays in treatment? Schizophr Bull. 2011 Sep;37 Suppl 2:S55-62. doi: 10.1093/schbul/sbr059. — View Citation
Twamley EW, Savla GN, Zurhellen CH, Heaton RK, Jeste DV. Development and Pilot Testing of a Novel Compensatory Cognitive Training Intervention for People with Psychosis. Am J Psychiatr Rehabil. 2008 Apr;11(2):144-163. — View Citation
Twamley EW, Thomas KR, Burton CZ, Vella L, Jeste DV, Heaton RK, McGurk SR. Compensatory cognitive training for people with severe mental illnesses in supported employment: A randomized controlled trial. Schizophr Res. 2019 Jan;203:41-48. doi: 10.1016/j.schres.2017.08.005. Epub 2017 Aug 18. — View Citation
Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline functional capacity at 12 weeks : The Observed Tasks of Daily Living-Revised (OTDL-R) | OTDL-R is an objective, performance-based evaluation of the subjects' ability to perform daily life activities in the following areas: Medication management, communication and finances management. The final score ranges from 0 (not independent) to 28 (independent). | 30 min duration at week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: The Cognitive Problems and Strategies Assessment (CPSA) | CPSA is a self-reported questionnaire on personal experience of cognitive difficulties and usage of cognitive strategies. The final score for each scale ranges from 0 (Rarely/ Never) to 3 (always) | 10 min at week 0 ; week 12 | |
Secondary | Change from baseline severity of clinical symptoms at 12 weeks: Clinical Global Impression (CGI) | a scale used by the clinician to assess the severity of symptoms according to symptoms, behaviour and function in the last week. The final score ranges from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients) | week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: The Neurobehavioral Cognitive Status Examination (COGNISTAT) | COGNISTAT is a cognitive screening test for 3 basic cognitive functions: Orientation, Attention, Memory Registration and 5 major cognitive functions: Language (Comprehension, Repetition, Naming), Constructional Ability, Memory, Calculation Skills, Executive Skills (Reasoning, Judgment). The final scores for the subtests ranges from 0 (severe impairment) to 4, 6, 8 or 12 (average range) | 20 min at week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: Rey- Ostereich Complex Figure | a cognitive performance test evaluating instant visual memory and visual organization. The final score for accuracy ranges from 0-36 as higher score indicate better accuracy. The final score for the general performance of the task ranges from 1 (very reasonable) to 7 (not at all reasonable). | 20 min at week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: Trail Making Test A & B (TMT) | Paper and pencil neuropsychological test that evaluating processing speed and shifting. The final score represents the time length in which the subject completed the test. | 3 min at week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: Behavioral Assessment of the Dysexecutive Syndrome (BADS): key searching test | a cognitive performance test evaluating problem solving, regulating and monitoring behavior. The final score ranges from 0-4, Higher score is a better result. | 1 min at week 0 ; week 12 | |
Secondary | Change from baseline cognitive functions at 12 weeks: Category Fluency Test (CFT) | A neuropsychological test evaluating the ability to retrieve information from memory in a limited amount of time. The final score represents the number of words the subject succeeded to retrieve in the limited time. Higher score is a better result. | 1 min at week 0 ; week 12 |
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